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A committee of distinguished medical experts has formally criticized the Federal Food and Drug Administration for allowing too many children to take anti-psychotic drugs.

The committee of doctors and professors was supposed to approve the FDA's current monitoring of these drugs, but instead expressed concern that the medications pose certain risks to young children.

The medications under review are Risperdal, Xyprexa, Seroquel, Abilify, and Geodon. More than 389,000 children - 240,000 of whom are under the age of 12 - take these drugs, which can produce side effects that include weight gain, metabolic disorders, and muscular tics.

"We are concerned about some of the side effects that [these drugs] have because they affect multiple organ systems," Dr. Keith Kocis, a professor from the University of North Carolina at Chapel Hill, said in an interview with Reuters.

One drug that aroused considerable concern among the physicians is Risperdal.

"The data show that there is a substantial amount of prescribing Risperdal for attention deficit disorder," said Dr. Daniel Notterman, a senior health policy analyst at Princeton University and a member of the committee. "I wonder if we have given enough weight to the adverse event profile of the drug in light of this."

Between 1993 and March 2008, about 1,200 children taking Risperdal had severe side effects and 31 children died, according to documents submitted to the panel.

A spokesperson for Johnson & Johnson, maker of Risperdal, said that the drug already carries a strong warning label for parents.

Labels: anti-depression medications, drugs. antidepressants

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A study by researchers with the University of Maryland found that American children are using antidepressants and stimulants at three times the rate of European children. American pediatric use of antipsychotic drugs was twice that of the German and Dutch rate.

Lead author Julie Zito and her colleagues went through data on 600,000 persons under 19 years old, and found that seven percent of American children were taking such psychotropic drugs, This compared to 2.9 percent of the Dutch and 2.0 percent of German children. Among American children ages 5 to 9 years old, one in twelve was taking psychotropic drugs, among European children of the same ages, the rate was one in 48.

Zito said she believes that differences in culture, in the way behavioral disorders are classified, and in insurance and government reimbursements may account for the discrepancies. Other potential causes include the following: European drug companies are banned from advertising to consumers; the European diagnosis of hyperkinetic disorder has more stringent guidelines than the American equivalent of Attention Deficit Hyperactivity Disorder; there are many more psychiatrists in the States; and some drugs were banned for European use during the course of the study.

This study appears in the journal BioMed Central.

Labels: drugs. antidepressants, stimulants

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